Clinical trial · Interventional
Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy
Traditional Chinese Medicine as Preventive Method for Osteoporosis in Early Breast Cancer Patients Receiving Adjuvant Endocrine Therapy
NCT02455154CI-TRIAL-00044638COATcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
| Xianlinggubao | Drug | — | UNRESOLVED |
| Zhongyaofufang | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Letrozole
- description
- Early Breast Cancer patients receiving adjuvant endocrine therapy Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.
- interventionNames
- Drug: Letrozole
- type
- ACTIVE_COMPARATOR
- label
- Letrozole + Xinglinggubao
- description
- Early Breast Cancer patients receiving adjuvant endocrine therapy plus Xianlinggubao Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Xinglinggubao: 0.5g bid po
- interventionNames
- Drug: Letrozole
- Drug: Xianlinggubao
- type
- ACTIVE_COMPARATOR
- label
- Letrozole + Zhongyaofufang
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive breast cancer; * Post-surgery, primary lesion been removed; * Post-Menopausal patients or pre-menopausal patients who will receive ovarian function suppression; * Histologically confirmed ER and/or PR positive ; * Receiving adjuvant AIs therapy in the following one years; * Leukocyte ≥ 3\*10(9)/L; Platelets ≥ 75\*10(9)/L; * Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) \<2.5 times of upper limit of normal range; * Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range; * Written informed consent according to the local ethics committee equirements; Exclusion Criteria: * Metastatic Breast Cancer; * Received Neo-Adjuvant Endocrine Therapy; * History of pelvic fracture or bone metabolic disease; * Received drugs interfering bone metabolism in the last 12 months; * Baseline Bone Mineral Density: T \< -2SD; * With other primary malignant disease; * With severe non-malignant co-morbidity that will influence long-term follow up; * Known severe hypersensitivity to any drugs in this study;
References
Publications (0)
Data not yet available
No reference posted for this study.